Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597357
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Evaluation of Clinical and Radiographic Outcomes of Meniscal Lesion Treatment Using Collagen Scaffolds CMI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Clinical and Radiographic Outcomes of Meniscal Lesion Treatment Using Collagen Scaffolds CMI
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPER CMI
Brief Summary:
Meniscal lesions represent the most frequently encountered joint pathology in the adult population and can cause pain symptoms mechanical blockages and recurrent effusions The treatment of these lesions has progressively evolved from meniscectomy removal of the damaged meniscal tissue to the use of meniscal sutures where possible to preserve as much meniscus as possible Numerous studies have demonstrated a correlation between the amount of meniscus removed and the future onset of osteoarthritis
However in some cases especially in the presence of complex andor chronic lesions meniscectomy remains the only viable surgical option Over time months or years later a subgroup of patients may develop symptoms such as pain joint swelling and mechanical overload of the compartment that underwent meniscectomy a condition known as post-meniscectomy syndromeA portion of these patients will later develop knee osteoarthritis and require invasive procedures such as partial or total knee replacement
In an attempt to treat this condition scaffolds-collagen implants-have been developed and are arthroscopically implanted in the knee with the aim of functionally replacing the tissue removed during surgery The goal is to reduce the incidence of long-term osteoarthritis and consequently the need for more invasive procedures To date no study has definitively demonstrated the real efficacy of these scaffolds CMI particularly regarding chondroprotection and the long-term onset of osteoarthritis
However in some cases especially in the presence of complex andor chronic lesions meniscectomy remains the only viable surgical option Over time months or years later a subgroup of patients may develop symptoms such as pain joint swelling and mechanical overload of the compartment that underwent meniscectomy a condition known as post-meniscectomy syndromeA portion of these patients will later develop knee osteoarthritis and require invasive procedures such as partial or total knee replacement
In an attempt to treat this condition scaffolds-collagen implants-have been developed and are arthroscopically implanted in the knee with the aim of functionally replacing the tissue removed during surgery The goal is to reduce the incidence of long-term osteoarthritis and consequently the need for more invasive procedures To date no study has definitively demonstrated the real efficacy of these scaffolds CMI particularly regarding chondroprotection and the long-term onset of osteoarthritis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None